Course Description:
This course focuses on the control of residual solvents in pharmaceutical products to ensure patient safety. It is primarily based on USP General Chapters <467> and <1467>, and the ICH Q3C guideline. The course covers the classification, allowed limits, and control strategies for residual solvents, including what to do if a solvent is not listed. It also discusses regulatory aspects, identification, control, and quantitation of residual solvents, and provides detailed explanations of analytical procedures and criteria for their suitability and alternatives. The course includes examples of chromatograms with associated conditions.
Key topics include the following:
- Historical approaches and standards in USP General Chapter <467>
- Risk-Based Classification of Residual Solvents
- Risk-based strategy concept for complying with residual solvents content in pharmaceutical requirements of USP <467>
- Examples of using Options 1 and 2 for Control of Class 2 and Class 3 Residual Solvents, and Procedures A, B, and C as described in USP <467>
- Validation and verification requirements in USP General Chapter <1467>
- Validation and performance criteria when using alternative procedures
- Chromatographic systems and analytical procedures
- FDA guidance and CFR sections related to residual solvents
- Recent revisions to USP <467> and <1467>
The most recent revision, to be official on August 1st, 2025, was performed to align the chapter with ICH Q3C(R9). This revision introduced two new Class 2 Residual Solvents, Cyclopentyl methyl ether with a PDE of 15 mg/day and tertiary butyl alcohol with a PDE of 35 mg/day, and a new Class 3 Residual Solvent, 2-Methyltetrahydrofuran.
Upon completion of this course, you will be able to
- Understand the historical approaches and standards contained in USP General Chapter <467>.
- Apply a risk-based strategy concept for complying with residual solvents content in pharmaceutical requirements of USP <467>.
- Illustrate Options 1 and 2, as well as Procedures A, B, and C as described in USP <467>.
- Differentiate between validation and verification and understand when to use alternative procedures.
- Understand validation and verification requirements as described in USP General Chapter <1467>.
Who should participate:
- QC/QA
- Compliance staff
- Laboratory scientists
- Managers in the pharmaceutical and allied industries
- Regulatory professionals